Severe acute respiratory syndrome-associated coronavirus IVDs

Intended purpose

Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 from symptomatic individuals at the point of care by trained health professionals (whole blood, serum, plasma, nasal swabs, nasopharyngeal swabs and nasal wash/aspirate) and for self-testing by lay persons with or without symptoms (nasal swabs).